The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Ps Medical Strata Ii Valve.
| Device ID | K042465 |
| 510k Number | K042465 |
| Device Name: | PS MEDICAL STRATA II VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2004-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994803740 | K042465 | 000 |
| 00643169975743 | K042465 | 000 |
| 00643169472990 | K042465 | 000 |
| 00643169472983 | K042465 | 000 |
| 00643169472778 | K042465 | 000 |
| 00643169466432 | K042465 | 000 |
| 00643169466425 | K042465 | 000 |
| 00885074228150 | K042465 | 000 |
| 00763000030803 | K042465 | 000 |
| 00763000028893 | K042465 | 000 |
| 00763000027964 | K042465 | 000 |
| 00763000027957 | K042465 | 000 |
| 00643169975750 | K042465 | 000 |
| 00643169975767 | K042465 | 000 |
| 00613994803733 | K042465 | 000 |
| 00613994803719 | K042465 | 000 |
| 00613994721662 | K042465 | 000 |
| 00613994721655 | K042465 | 000 |
| 00613994721648 | K042465 | 000 |
| 00613994721631 | K042465 | 000 |
| 00613994721624 | K042465 | 000 |
| 00613994721617 | K042465 | 000 |
| 00613994556554 | K042465 | 000 |
| 00613994346889 | K042465 | 000 |
| 00613994128584 | K042465 | 000 |
| 00763000027117 | K042465 | 000 |